Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The following Office action in response to communications received November 21, 2025. Claims 1-2, 6, 8-9, 11, 13, 15-7 and 19 have been amended. Claims 9 and 10 have been added. Therefore, claims 1-10 are pending and addressed below.
Applicant’s amendments to the claims are not sufficient to overcome the rejections set forth in the previous office action dated August 21, 2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Independent Claim(s) 1 and 11 are directed to an abstract idea comprising systems and methods for collecting data from multiple laboratory sources, linking it to a shared project based on data type, creating and reporting an overlaid chromatogram as part of a bioprocessing step, and enabling collaborative access with change tracking for project data.
Independent Claim 1 recites “retrieve a first data set; retrieve a second data set; link the first data set and the second data set to a project, the first data and the second data set linked to the project based on a type of data in the first data set and the second data set; generate a data overlay using the first data set and the second data set, the data overlay including an overlay of a first chromatogram and a second chromatogram; displaying the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period; generate a report including the data overlay, the data overlay a result of a bioprocessing step associated with the project; link the report to the project, the project accessible to at least two users associated with the project; and track changes made by the at least two users to the first data set or the second data set associated with the report.”
Independent Claim 8 recites “retrieve a first data set; retrieve a second data set; link the first data set and the second data set to a project, the first data and the second data set linked to the project based on a type of data in the first data set and the second data set; generate a data overlay using the first data set and the second data set, the data overlay including an overlay of a first chromatogram and a second chromatogram; displaying the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period; generate a report including the data overlay, the data overlay a result of a bioprocessing step associated with the project; link the report to the project, the project accessible to at least two users associated with the project; and track changes made by the at least two users to the first data set or the second data set associated with the report.”
Independent Claim 15 recites “retrieve a first data set; retrieve a second data set; link the first data set and the second data set to a project, the first data and the second data set linked to the project based on a type of data in the first data set and the second data set; generate a data overlay using the first data set and the second data set, the data overlay including an overlay of a first chromatogram and a second chromatogram; displaying the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period; generate a report including the data overlay, the data overlay a result of a bioprocessing step associated with the project; link the report to the project, the project accessible to at least two users associated with the project; and track changes made by the at least two users to the first data set or the second data set associated with the report.”
The limitations of Claims 1, 8 and 15, as drafted, under its broadest reasonable interpretation, covers the performance of a Mental Process which are concepts performed in the human mind (including an observation, evaluation, judgment, opinion) and/or Certain Methods of Organizing Human Activity which are concepts performed by managing personal behavior, relationships or interactions between people (including fundamental economic principles, commercial or legal interactions, social activities, teaching, and following rules or instructions). That is, other than reciting, “memory, processor circuitry, electronic laboratory notebook” nothing in the claim element precludes the step from practically being performed in the mind and/or following rules or instructions. For example, but for the “laboratory device” language, “retrieving” in the context of this claim encompasses the user manually obtaining a first data set. Similarly, the obtaining, obtaining a second data set, covers performance of the limitation practically being performed in the mind and/or following rules or instructions, but for the recitation of generic computer components. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation practically being performed in the mind and/or following rules or instructions, but for the recitation of generic computer components, then it falls within the “Mental Processes and/or Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “memory, processor circuitry, local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first laboratory device, electronic laboratory notebook” to perform all of the “obtaining, transforming, parsing, determining, transforming, selecting and storing” steps. The “memory, processor circuitry, electronic laboratory notebook or a laboratory device” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claim 1 has the following additional elements (i.e., memory, processor circuitry, local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first laboratory device, electronic laboratory notebook). Claim 8 has the following additional elements (i.e., local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first laboratory device, electronic laboratory notebook. Claim 15 has the following additional elements (i.e., processor, local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first laboratory device, electronic laboratory notebook). Looking to the specification, these components are described at a high level of generality (see at least ¶ 81 and 102; The example software distribution platform 1805 may be implemented by any computer server, data facility, cloud service, etc., capable of storing and transmitting software to other computing devices.). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
It is worth noting that the above analysis already encompasses each of the current dependent claims (i.e., claims 2-7, 9-14 and 16-20). Particularly, each of the dependent claims also fails to amount to “significantly more’ than the abstract idea since each dependent claim is directed to a further abstract idea, and/or a further conventional computer element/function utilized to facilitate the abstract idea. Accordingly, none of the current claims implements an element—or a combination of elements—directed to an inventive concept (e.g., none of the current claims is reciting an element—or a combination of elements—that provides a technological improvement over the existing/conventional technology). These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Processes and/or Certain Methods of Organizing Human Activity,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claims 1-20 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pub. No.: US 20150112708 A1 to Heniford et al. in view of Pat. No.: US 10931643 B1 to Scolari et al.
As per Claim 1, Heniford et al. teaches a system for process data management, the system comprising:
-- memory; and processor circuitry to execute machine readable instructions to at least (see Heniford et al. paragraph 87; These computer program instructions may also be stored in a computer-readable memory that may direct a computer or other programmable apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture the execution of which implements the function specified in the flowchart blocks.):
-- retrieve a first data set from at least one of an electronic laboratory notebook or a first laboratory device (see Heniford et al. paragraph 69; FIG. 4 provides a flow chart illustrating operations for merging datasets from separate and distinct dictated notes systems and generating a superset of merged data for searching and analysis in accordance with an example embodiment of the present invention.);
-- retrieve a second data set from a second laboratory device (see Heniford et al. paragraph 69; FIG. 4 provides a flow chart illustrating operations for merging datasets from separate and distinct dictated notes systems and generating a superset of merged data for searching and analysis in accordance with an example embodiment of the present invention.);
-- link the first data set and the second data set to a project, the first data and the second data set linked to the project based on a type of data in the first data set and the second data set (see Heniford et al. paragraph 72; At block 404, the first dataset and the second dataset may be analyzed to determine records having matching first-level identifiers, such as medical record numbers associated with the endoscopy exams and pathology cases. At block 406, for each of the records of the first dataset and second dataset matched in block 404, the first dataset record identifier is linked to the second dataset record identifier. For example, in some embodiments, for each matched record in the endoscopy and pathology datasets, the endoscopy record Exam ID is linked to the pathology record Case ID.).
Heniford et al. fails to explicitly teach:
-- initiate a connection with a local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first laboratory device, the ELN including a record associated with at least one of a buffer, a filtration, a chromatogram, a bioreactor, or a batch report;
-- generate a data overlay using the first data set and the second data set, the data overlay including an overlay of a first chromatogram and a second chromatogram;
-- display the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period;
-- generate a report including the data overlay, the data overlay a result of a bioprocessing step associated with the project;
-- link the report to the project, the project accessible to at least two users associated with the project; and
-- track changes made by the at least two users to the first data set or the second data set associated with the report.
Scolari et al. teaches chromatogram data 760 and a report 770 that is generated by the chromatogram analysis tool 240. The chromatogram data 760 can be divided into regions of the plots of chromatogram data 712, 722, 732, 742, 752. The chromatogram data 760 is displayed along with an overlay indicating each region number associated with the plots of chromatogram data 712, 722, 732, 742, 752. The chromatogram analysis tool 240 produces the report 770 from the chromatogram analysis data 760. The best-fit templates 714, 724, 734, 744, 754 for the plots of chromatogram data 712, 722, 732, 742, 752 of FIG. 7A are visualizations of the best-fit match templates determined by the chromatogram analysis tool for each region of the chromatogram data 760. The report 770 is generated based on the best-fit matches 714, 724, 734, 744, 754 for each region (see Scolari et al. paragraph 43).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include systems/methods as taught by reference Scolari et al. within the systems/methods as taught by reference Heniford et al. with the motivation of providing novel opportunities to analyze blood test data and more reliably distinguish between different response patterns produced by samples containing variants, thereby reducing the reliance on human analysts, who may be subject to making errors and require more time and training to reach diagnoses than may be achieved using technology (see Scolari et al. paragraph 4).
It is to be noted that said linking and tracking limitations further detail the workflow procedure and they are regarded as straight forward for the problem solution approach.
Heniford et al., Scolari et al. and ROSENBLATT et al. fail to explicitly teach:
-- initiate a connection with a local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first laboratory device, the ELN including a record associated with at least one of a buffer, a filtration, a chromatogram, a bioreactor, or a batch report.
ROSENBLATT et al. teaches a device may attempt a handshake using a networking protocol (e.g. TCP). In response to successfully completing the handshake, the device may transmit an instruction to the system, for example, over FTP (see ROSENBLATT et al. paragraph 225).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include systems/methods as taught by reference ROSENBLATT et al. with the systems/methods as taught by reference Heniford et al. and Scolari et al. with the motivation of providing a system with immediate and updated training and re-enforcement of procedures for medical device use. With consistent procedure instructions, procedure outcomes will be more consistent thereby protecting the reputation of the practitioner, the medical device provider, the hospital, and the like (see ROSENBLATT et al. paragraph 4).
As per Claim 2, Heniford et al., Scolari et al. and ROSENBLATT et al. teach the system of claim 1, wherein the electronic laboratory notebook, the first laboratory device, or the second laboratory device receives the report, the report including an integration of a first data file in parallel with a second data file (see Scolari et al. paragraph 43; The chromatogram data 760 can be divided into regions of the plots of chromatogram data 712, 722, 732, 742, 752. The chromatogram data 760 is displayed along with an overlay indicating each region number associated with the plots of chromatogram data 712, 722, 732, 742, 752. The chromatogram analysis tool 240 produces the report 770 from the chromatogram analysis data 760. The best-fit templates 714, 724, 734, 744, 754 for the plots of chromatogram data 712, 722, 732, 742, 752 of FIG. 7A are visualizations of the best-fit match templates determined by the chromatogram analysis tool for each region of the chromatogram data 760. The report 770 is generated based on the best-fit matches 714, 724, 734, 744, 754 for each region).
The obviousness of combining the teachings of Heniford et al., Scolari et al. and ROSENBLATT et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 3, Heniford et al., Scolari et al. and ROSENBLATT et al. teach the system of claim 1, wherein the processor circuitry is to link the first data set to a project to make the first data set searchable in relation to the project (see Scolari et al. paragraph 48; To provide a more manageable format for searching and analyzing, the extracted dataset, such as exams dataset 104, may be converted into a systematic data structure. For example, in some embodiments, the extracted dataset may be modified and imported into a table in a relational database and then converted to a plurality of relational tables, such as relational database 106. Database 106 may then provide means for querying the exam data in a simpler and more manageable fashion for clinical monitoring and research.).
The obviousness of combining the teachings of Heniford et al., Scolari et al. and ROSENBLATT et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 4, Heniford et al., Scolari et al. and ROSENBLATT et al. teach the system of claim 1, further including processor circuitry to negotiate at least one parameter between the system for process data management and a data source system (see Scolari et al. paragraph 43; The chromatogram data 760 can be divided into regions of the plots of chromatogram data 712, 722, 732, 742, 752. The chromatogram data 760 is displayed along with an overlay indicating each region number associated with the plots of chromatogram data 712, 722, 732, 742, 752. The chromatogram analysis tool 240 produces the report 770 from the chromatogram analysis data 760. The best-fit templates 714, 724, 734, 744, 754 for the plots of chromatogram data 712, 722, 732, 742, 752 of FIG. 7A are visualizations of the best-fit match templates determined by the chromatogram analysis tool for each region of the chromatogram data 760. The report 770 is generated based on the best-fit matches 714, 724, 734, 744, 754 for each region).
The obviousness of combining the teachings of Heniford et al., Scolari et al. and ROSENBLATT et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 5, Heniford et al., Scolari et al. and ROSENBLATT et al. teach the system of claim 4, wherein the at least one parameter includes an information transfer rate or an interrupt procedure (see Scolari et al. paragraph 43; The chromatogram data 760 can be divided into regions of the plots of chromatogram data 712, 722, 732, 742, 752. The chromatogram data 760 is displayed along with an overlay indicating each region number associated with the plots of chromatogram data 712, 722, 732, 742, 752. The chromatogram analysis tool 240 produces the report 770 from the chromatogram analysis data 760. The best-fit templates 714, 724, 734, 744, 754 for the plots of chromatogram data 712, 722, 732, 742, 752 of FIG. 7A are visualizations of the best-fit match templates determined by the chromatogram analysis tool for each region of the chromatogram data 760. The report 770 is generated based on the best-fit matches 714, 724, 734, 744, 754 for each region).
Examiner notes that all computers have an information transfer rate, which is the speed at which data can be moved between different parts of the computer or between the computer and other devices.
The obviousness of combining the teachings of Heniford et al., Scolari et al. and ROSENBLATT et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 6, Heniford et al., Scolari et al. and ROSENBLATT et al. teach the system of claim 1, further including processor circuitry to modify the first data set or the second data set data based on a desired assessment or a type of data output, the type of data output a graphical data output or a tabulated data output (see Scolari et al. paragraph 41; FIG. 7A shows example visual representations of regions of chromatogram data overlaid with best-fit match templates. FIG. 7A includes a visual representation 710 of region 1, a visual representation 720 of region 2, a visual representation 730 of region 3, a visual representation 740 of region 4, and a visual representation 750 of region 5. The region identification module 320 divides chromatogram data 760 (see FIG. 7B) into regions, which are represented by the visual representations 710, 720, 730, 740, 750. Each visual representation of 710, 720, 730, 740, 750 of each region includes a plot of chromatogram data 712, 722, 732, 742, 752 of the region and a best-fit template 714, 724, 734, 744, 754 determined by the template matching module 330, respectively. Each visual representation 710, 720, 730, 740, 750 also includes a summary of results 716, 726, 736, 746, 756, which provide an offset value and an R value for the match between the plot of chromatogram data 712, 722, 732, 742, 752 and the best-fit template 714, 724, 734, 744, 754, for each respective region, as determined by the template matching module 330.)
The obviousness of combining the teachings of Heniford et al., Scolari et al. and ROSENBLATT et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claim 7, Heniford et al., Scolari et al. and ROSENBLATT et al. teach the system of claim 1, further including processor circuitry to link the first data set to the second data set based on a user-based search entry, the first data set and the second data set a same data type, the data type including a graphical data type or a tabulated data type (see Scolari et al. paragraph 41; FIG. 7A shows example visual representations of regions of chromatogram data overlaid with best-fit match templates. FIG. 7A includes a visual representation 710 of region 1, a visual representation 720 of region 2, a visual representation 730 of region 3, a visual representation 740 of region 4, and a visual representation 750 of region 5. The region identification module 320 divides chromatogram data 760 (see FIG. 7B) into regions, which are represented by the visual representations 710, 720, 730, 740, 750. Each visual representation of 710, 720, 730, 740, 750 of each region includes a plot of chromatogram data 712, 722, 732, 742, 752 of the region and a best-fit template 714, 724, 734, 744, 754 determined by the template matching module 330, respectively. Each visual representation 710, 720, 730, 740, 750 also includes a summary of results 716, 726, 736, 746, 756, which provide an offset value and an R value for the match between the plot of chromatogram data 712, 722, 732, 742, 752 and the best-fit template 714, 724, 734, 744, 754, for each respective region, as determined by the template matching module 330.).
The obviousness of combining the teachings of Heniford et al., Scolari et al. and ROSENBLATT et al. are discussed in the rejection of claim 1, and incorporated herein.
As per Claims 8-14, Claims 8-14 are directed to a method for process data management. Claims 8-14 recite the same or substantially similar limitations as those addressed above for Claims 1-7 as taught by Heniford et al., Scolari et al. and ROSENBLATT et al. Claims 8-14 are therefore rejected for the same reasons as set forth above for Claims 1-7 respectively.
As per Claims 15-20, Claims 15-20 are directed to at least one computer readable storage medium comprising instructions. Claims 8-14 recite the same or substantially similar limitations as those addressed above for Claims 1-4 and 6-7 as taught by Heniford et al., Scolari et al. and ROSENBLATT et al. Claims 15-20 are therefore rejected for the same reasons as set forth above for Claims 1-4 and 6-7 respectively.
Response to Arguments
Applicant’s arguments filed November 21, 2025 have been fully considered but they are not persuasive. In the remarks applicant argues:
(1) The Rejections Under 35 U.S.C. § 101
The Office Action rejected claims 1-20 under 35 U.S.C. § 101 as allegedly directed to non-statutory subject matter. In particular, the Office Action alleges that claims 1-20 are directed to an abstract idea without significantly more. (Office Action, p. 2). The Applicant traverses the § 101 rejections.
The Rejection of Claims 1-20 As Allegedly Directed to an Abstract Idea
The Office Action argues that claims 1-20 are allegedly directed to an abstract idea without significantly more and, thus, are directed to non-statutory subject matter. The Applicant traverses the § 101 rejections. As discussed below, claims 1-20 are not directed to an abstract idea.
Independent Claim 1
Step 2A - Claim 1 is Not Directed to an Abstract Idea
Independent claim 1 is not directed to an abstract idea and, thus, satisfies step 2A of the test enunciated in Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). To identify a judicial exception under the first prong of Step 2A, the 2019 Revised Patent Subject Matter Eligibility Guidance (hereinafter "2019 Revised Guidance") sets forth three groupings of activities in which an abstract idea can be found. The three groupings include: mathematical concepts, certain methods of organizing human activity, and mental processes. These groupings do not apply to any of the claims of the instant application.
The Office Action alleges that claim 1 recites a mental process (Office Action, p. 3). However, the steps of claim 1 are not practically performed in the mind. For example, the apparatus of claim 1 includes processor circuitry to execute the instructions to, inter alia, initiate a connection with a local device using a transmission control protocol (TCP) handshake, retrieve a first data set from the local device, retrieve a second data set from a second laboratory device, link the first data set and the second data set to a project, the first data and the second data set linked to the project based on a type of data in the first data set and the second data set, and display the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period. For example, bioprocesses "require real-time, continuous measurement of process variables to ensure the stability, efficiency, and reproducibility of the processes to provide for a high-quality product... [and] [a] variety of bioprocess instruments... are used during upstream processing (e.g., biomass expansion, media development and preparation, etc.) and downstream processing (e.g., product extraction and purification from the biomass, etc.), including bioreactors and mixers." (See Instant Application, para. [0004], emphasis added).
The processor circuitry disclosed herein provides "a single platform for collecting, integrating, and/or evaluating data relevant to a given process that can also be user-specific (e.g., based on the data assessment and/or data evaluating needs of an analytical scientist versus a process development scientist, etc.)." (Id. at para. [0005], emphasis added). Furthermore, processor circuitry disclosed herein is associated with “cloud-based management of bioprocesses, such as chromatography... [that] permit[s] integrated data analysis and assessment, streamlined data reporting, and a platform-wide, accessible database of stored results" in addition to "collect[ing] data from different process (e.g., science and analytical) lab devices in upstream and downstream process development." (Id at para. [0033], emphasis added).
As such, the real-time data collection and analysis using the processor circuitry disclosed herein requires access to memory and cannot be practically performed in the human mind as the respective formats and quantities of the data would be impossible for a human mind to process, even with the help of pencil and paper. For example, like the patent eligible claim 2 of Example 37 (Relocation of Icons on a Graphical User Interface) provided by the USPTO, claim 1 does not recite a mental process that can be practically performed in the human mind. For example, the "determining step" of claim 2 of Example 37 requires action by a processor that cannot be practically applied in the mind. In particular, claim 2 includes "determining the amount of use of each icon using a processor that tracks how much memory has been allocated to each application associated with each icon over a predetermined period of time," and is found to not be practically performed in the human mind because this determining step requires a processor accessing computer memory. Similarly, claim 1 as disclosed herein requires the accessing of computer memory, given that collecting and analyzing data from different process lab devices in upstream and downstream process development is memory-intensive. Therefore, claim 1 does not recite a mental process because it does not contain limitations that can practically be performed in the human mind and/or the human mind is not equipped to perform the claim limitations.
The Office Action also alleges that claim 1 recites certain methods of organizing human activity (Office Action, p. 3). Claim 1 does not recite a method of organizing human activity. For example, while the focus of the instant application is the development of technology that would improve the technical field of bioprocess system monitoring that is associated with the organization and assessment of data outputs from bioprocess devices, the claims of the instant application are not directed towards any aspect of organizing human activity. As such, the instant application aims to improve bioprocess monitoring techniques through real-time, continuous measurement of process variables to ensure the stability, efficiency, and reproducibility of the bioprocesses. However, the claims themselves are not directed to commercial or legal interactions, fundamental economic principles, social activities, or the teaching and following of rules or instructions. As such, just because the claims of the instant application happen to benefit the industry of bioprocessing does not render them to represent commercial interactions.
Furthermore, claim 1 is grounded in a practical application of improving data organization and reporting associated with bioprocess device monitoring systems. For example, claim 1 permits the reduction of "time for data processing and/or analysis, increase[d] data integrity and traceability, and secure data for re-use across an entire organization." (Id. at para. [0103]). For example, claim 1 includes, inter alia, processor circuitry to link the first data set and the second data set to a project, the first data and the second data set linked to the project based on a type of data in the first data set and the second data set, generate a data overlay using the first data set and the second data set, the data overlay including an overlay of a first chromatogram and a second chromatogram, display the data overlay, generate a report including the data overlay, the data overlay a result of a bioprocessing step associated with the project, link the report to the project, the project accessible to at least two users associated with the project, and track changes made by the at least two users to the first data set or the second data set associated with the report. As such, claim 1 is not directed to a judicial exception and is patent eligible under Step 2A.
Step 2B - Claim 1 Amounts to Significantly More than an Abstract Idea
The particular arrangement of elements in claim 1 of the instant application
results in a technical improvement in the field of bioprocess monitoring and, in particular, with respect to deficiencies associated with centralized data management systems, "there is a need for a centralized data management system that would provide a single platform for collecting, integrating, and/or evaluating data relevant to a given process that can also be user-specific (e.g., based on the data assessment and/or data evaluating needs of an analytical scientist versus a process development scientist, etc.). (Instant Application, para. [0005], emphasis added). For example, the instant application discloses multiple examples of how the claimed subject matter provides improvements over known bioprocess monitoring techniques. As disclosed in the present specification, the claimed subject matter provides for addressing challenges associated with processing data organization and reporting. For example, "during a given bioprocess, a large amount of data is stored, communicated, and shared across various platforms that are not integrated. For example, multiple individuals (e.g., analytical scientist(s), process development scientist(s), technical project leader(s), etc.) may need to access, modify, and/or validate data collected over the duration of a given bioprocess or afterwards. Every individual can use multiple methods of data collection, assessment, and/or storage (e.g., Excel file, electronic laboratory notebook (ELN), etc.)." (Id. at para. [0005], emphasis added).
The technological improvements provided for improved data monitoring of bioprocess devices are expressly incorporated into claim 1. For example, claim 1 focuses on processor circuitry to link the first data set and the second data set to a project, the first data and the second data set linked to the project based on a type of data in the first data set and the second data set, generate a data overlay using the first data set and the second data set, the data overlay including an overlay of a first chromatogram and a second chromatogram, display the data overlay, generate a report including the data overlay, the data overlay a result of a bioprocessing step associated with the project, link the report to the project, the project accessible to at least two users associated with the project, and track changes made by the at least two users to the first data set or the second data set associated with the report. Accordingly, independent claim 1 and all claims depending therefrom are directed to statutory subject matter in compliance with 35 U.S.C. § 101 under step 2A and 2B of the Alice test.
Likewise, independent claims 8 and 15, and all claims depending respectively therefrom, sets forth patent eligible subject matter under the 2019 Revised Guidance. Therefore, withdrawal of the § 101 rejections of independent claims 1, 8 and 15, and all claims depending respectively therefrom, is requested.
(2) Rejections Under 35 U.S.C. § 103
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over
Heniford et al., U.S. Patent Application Publication No. 2015/0112708 (hereinafter "Heniford") in view over Scolari et al. (U.S. Patent No. 10,931,643). The Applicant respectfully traverses the art-based rejections.
Independent Claim 1
Claim 1 sets forth a system for process data management, the system including memory and processor circuitry to execute machine readable instructions to at least display the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period. Heniford in view of Scolari does not teach or suggest such a system for process data management.
Heniford mentions methods and systems for merging and analyzing healthcare data, including "extracting and standardizing data from dictated notes systems to provide a manageable format for search and analysis in clinical research and monitoring applications" (see Abstract). As acknowledged in the Office Action, "Heniford et al. fails to explicitly teach...generate a data overlay using the first data set and the second data set..." (see Office Action, p. 7). Accordingly, Heniford does not teach or suggest a system for process data management, the system including memory and processor circuitry to execute machine readable instructions to at least display the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period, as set forth in claim 1.
Scolari does not remedy the limitations of Heniford. Scolari mentions automated chromatogram analysis for blood test evaluation, including "a best-fit match for each region [of the data] by comparing the blood test data to a set of templates associated with archetypical shapes of the region" (see Abstract). Scolari further mentions that "chromatogram data 760 is displayed along with an overlay indicating each region number associated with the plots of chromatogram data 712, 722, 732, 742, 752" (see para. [0043]). However, Scolari does not teach or suggest a system for process data management, the system including memory and processor circuitry to execute machine readable instructions to at least display the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period, as set forth in claim 1.
Because each of Heniford and Scolari are missing the same elements of claim 1, the alleged Heniford/Scolari combination is missing those same elements of claim 1. Therefore, the combination does not teach or suggest the system of claim 1. Withdrawal of the §103 rejections of claim 1 and all claims dependent thereon is respectfully requested.
Independent Claim 8
Claim 8 sets forth a method for process data management, the method including displaying the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period. As described in connection with claim 1, the alleged Heniford/Scolari combination is missing those same elements of claim 8. Withdrawal of the §103 rejections of claim 8 and all claims dependent thereon is respectfully requested.
Independent Claim 15
Claim 15 sets forth at least one computer readable storage medium comprising instructions that, when executed, cause at least one processor to at least display the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period. As described in connection with claim 1, the alleged Heniford/Scolari combination is missing those same elements of claim 15. Withdrawal of the §103 rejections of claim 15 and all claims dependent thereon is respectfully requested.
In response to argument (1), Examiner respectfully disagrees. The claims lack limitations that are indicative of an inventive concept (aka “significantly more”). The claimed limitations must include one or more of an improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a); applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b); effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c); applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo; and/or adding a specific limitation other than what is well-understood, routine, conventional activity in the field - see MPEP 2106.05(d).
The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
To conclude, the claimed techniques that are inherently associated with and dependent on artificial intelligence, machine learning, or neural networks are simply ways to make the analysis more efficient by using at least artificial intelligence (e.g. computer) to do what they are made to do with no technological improvement.
In response to argument (2), Examiner respectfully disagrees. As cited, Heniford et al. paragraph 87 teaches a computer program instruction may also be stored in a computer-readable memory that may direct a computer or other programmable apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture the execution of which implements the function specified in the flowchart blocks.
In addition, the new prior art ROSENBLATT et al. teaches methods and/or processes, and steps associated therewith, may be realized in hardware, software or any combination of hardware and software suitable for a particular application. The hardware may include a general-purpose computer and/or dedicated computing device or specific computing device or particular aspect or component of a specific computing device. The processes may be realized in one or more microprocessors, microcontrollers, embedded microcontrollers, programmable digital signal processors or other programmable device, along with internal and/or external memory. The processes may also, or instead, be embodied in an application specific integrated circuit, a programmable gate array, programmable array logic, or any other device or combination of devices that may be configured to process electronic signals. It will further be appreciated that one or more of the processes may be realized as a computer executable code capable of being executed on a machine readable medium (see ROSENBLATT et al. paragraph 329).
Therefore, the rejection of the previous Office Action is maintained in view of Heniford et al., Scolari et al. and ROSENBLATT et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2014127379 A1; Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
WO 2010086862 A1; The present invention provides an electronic laboratory notebook system and method, for planning a research experiment and recording experimental data in a database. Experimental data, protocol and results, may be retrieved and analyzed using the invention. In one embodiment, the electronic notebook of the invention outputs a pictorial image of experimental samples included in a predetermined experiment. The image may include the concentration of all reagents in a sample, and the location of each sample in the experimental design. In some embodiments, the invention provides budget planning and inventory management, wherein dataflow occurs between various fields allowing automatic depletion of inventory upon performance of an experiment, and allowing preparation of cost estimates for performing an experiment.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.B.W/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683